Child-resistant packaging for pharmaceutical products

ABSTRACT

A child-resistant package for pharmaceutical articles includes a blister pack having a product casing layer defining blisters, a foil closure layer enclosing articles in the blisters and a reinforcing layer preventing dispensing of each article until an access mechanism is used. Each access mechanism includes a puncturing element of the product casing layer and a tear-away element of the reinforcing layer defined by a perforation line. The puncturing element includes a pointed portion for separating a first end of the tear-away element. Application of pulling force to the first end further separates the tear-away element to expose the foil layer adjacent the blister for dispensing the article. According to one embodiment, the package includes an outer jacket having a mounting portion receiving the blister pack and a cover movable with respect to the mounting portion between opened and closed positions.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority of U.S. Provisional Application No.60/777,346, filed Feb. 28, 2006.

FIELD OF THE INVENTION

The invention relates to packaging and, more particularly, tochild-resistant packaging for phannaccutical products in the form ofpills, tablets or capsules.

BACKGROUND OF THE INVENTION

Blister packaging for pharmaceutical products such as pills, tablets,and capsules includes a product casing layer and a foil closure layer.The product casing layer is formed from a moldable material to defineblisters each adapted to receive one of the pills, tablets, or capsuleswithin an interior of the blister. The foil closure layer is secured toa base portion of the product casing layer surrounding the blisters(e.g., by heat-sealing) to enclose the pills, tablets, or capsuleswithin the blisters. To dispense the pills, tablets, or capsules fromthe packaging, a user depresses one of the blisters such that theenclosed product is driven into compressive contact with the foil layerwith sufficient force to rupture the foil layer.

Child-resistant packaging for pharmaceutical products include featuresrequiring certain cognitive skills for gaining access to, or dispensing,the phannaceutical product such that access to the pharmaceuticalproduct by a young child is limited. A well known example is thetwist-off cap for a pill bottle that requires application ofsimultaneous twisting and axial forces to remove the cap. Forblister-type packages, it is known to include an outer package forcontaining a blister pack in which either or both the outer package andblister pack must be manipulated in a certain manner to provide fordispensing of the pharmaceutical product. For example, it is known toprovide a blister pack slidably mounted in an outer package for movementof the blister pack with respect to the outer package between first andsecond positions. Openings in the outer package are respectivelymisaligned and aligned with the blisters of the blister pack in thefirst and second positions to disable and enable a dispensing actuationof the blisters.

Prior child-resistant packages, which desirably function to limit accessto the contents by small children, also can undesirably limit access tothe contents by elderly or infirm patients who, although possessing thenecessary cognitive skills, lack sufficient strength or manual dexterityto manipulate the packaging in the required manner. Also, the featuresof prior child-resistant packaging that operate to limit access may addsignificant expense to the packaging, particularly packaging requiringinteraction between an outer package and a blister pack housed withinthe outer package.

What is needed is a child-resistant package for pharmaceutical productssuch as pills, capsules, and tablets that functions to limit access tothe package contents by a small child who may be harmed by the contentsbut that also provides for access to the contents of the package by anelderly or infirm person having limited strength or dexterity. Moreparticularly, what is needed is a blister-type packaging forpharmaceutical products in which the child-resistant features may beincluded in a stand-alone blister pack having a relatively uncomplicatedconstruction for providing cost-saving efficiencies.

SUMMARY OF THE INVENTION

According to one aspect of the invention, there is provided achild-resistant packaging for pharmaceutical articles such as pills,tablets, and capsules comprising a blister pack having a product casinglayer and a foil closure layer. The product casing layer includes aplurality of blisters each defining an interior for receiving one of thearticles. The foil closure layer is secured to the product casing layerto enclose the articles within the blisters. The packaging also includesa reinforcing layer adapted to limit dispensing of the articles from thepackage until an access mechanism of the package has been actuated by auser.

The packaging includes a plurality of access mechanisms each associatedwith one of the blisters to provide for dispensing of the articlecontained within the blister following actuation of the accessmechanism. Each access mechanism includes a puncturing element definedby the product casing layer and a tear-away element defined by thereinforcing layer. The puncturing element preferably includes a conicalouter wall portion and an inner wall portion supported by the outer wallportion and having a pointed end portion. The tear-away element of theaccess mechanism is preferably defined by weakening the reinforcinglayer, most preferably by a perforation line. The tear-away elementincludes a first end located beneath the associated puncturing elementand an opposite second end located beneath the associated blister.

The inner wall portion of the puncturing element is adapted to deflectunder a compressive load applied to the puncturing element. This resultsin application of a separating pressure to the reinforcing layer and thefoil layer sufficient to separate the first end of the associatedtear-away element from an adjacent base portion of the reinforcinglayer. The separation of the first end facilitates grasping of thetear-away element for application of a pulling force to the tear-awayelement to advance an opening in the reinforcing layer towards thesecond end of the tear-away element. According to one embodiment, thetear-away element is reduced in width adjacent the first end to increasethe separating pressure for a given applied load. The tear-away elementmay also be made weaker adjacent the first end, for example byincreasing the percentage of perforation in a perforation line definingthe tear-away element.

Prior to actuation of the access mechanism, the presence of thereinforcing layer beneath the associated blister prevents a user fromdispensing the article from the blister by application of a compressiveload to the blister in the conventional manner. To dispense the article,a user first applies a compressive load to the puncturing element of theaccess mechanism of sufficient magnitude to separate the first end ofthe associated tear-away element from the adjacent base portion of thereinforcing layer. Next, the user grasps the first end of the tear-awayelement and applies a pulling force to the tear-away element such thatan access opening in the reinforcing element is advanced toward to thesecond end of the tear-away element. Following sufficient advancement ofthe access opening toward the second end of the tear-away element, theuser may then dispense the article by applying a compressive load to theblister of sufficient magnitude such that the foil closure layer isruptured by the article.

According to one embodiment of the invention, the blister pack ismounted in an outer jacket. The jacket includes a mounting portionhaving front and back panels. Preferably, the front panel definesopenings adapted for receipt of the blisters and puncturing elementsdefined by the product casing layer of the packaging. Preferably, thejacket also includes a cover panel and a relatively narrow intermediatepanel located between the cover panel and the mounting portion such thatthe cover panel can be moved between opened and closed positions withrespect to the mounting portion of the jacket.

BRIEF DESCRIPTION OF THE DRAWINGS

For the purpose of illustrating the invention, there is shown in thedrawings a form that is presently preferred; it being understood,however, that this invention is not limited to the precise arrangementsand instrumentalities shown.

FIG. 1 is a perspective view of a child-resistant package forpharmaceutical products according to an exemplary embodiment of thepresent invention.

FIG. 2 is an exploded perspective view of a child-resistant packageaccording to an exemplary embodiment of the invention.

FIG. 3 is a sectional view of a product casing layer of thechild-resistant package of FIG. 1 taken along line 3-3 in FIG. 2.

FIG. 4 is a perspective view of a child-resistant package according to asecond exemplary embodiment of the invention.

FIG. 5 is a sectional view of the packaging of FIG. 4 taken along theline 5-5 of FIG. 4.

FIG. 6 is a bottom view of a mounting portion of a jacket of thepackaging of FIG. 4.

FIGS. 7 and 8 are plan views of child-resistant packages forphannaceutical products, the packages being respectively 7 and 14 countpackages.

DESCRIPTION OF THE INVENTION

Referring to the drawings, there is shown in FIGS. 1 through 3 a package10 for pharmaceutical products such as pills, tablets, capsules, and thelike. The pharmaceutical products for use with the package 10 arehereinafter sometimes referred to as “pills” to facilitate description.It should be understood, however, that the invention is not so limited.Referring to FIGS. 1 and 2, the depicted package 10 includes a productcasing layer 12, a foil (e.g., aluminum) closure layer 14 and areinforcing layer 16. The product casing layer 12 includes a pluralityof blisters 18 each defining an interior for receipt of a pill. Thepackage 10 includes a plurality of access mechanisms 20 each associatedwith one of the blisters 18. The access mechanism 20 is adapted tocreate an opening in the reinforcing layer 16 to provide for dispensinga pill from the blister 18. As described below in greater detail, theaccess mechanism 20 of the present invention provides a child-resistantfeature because successful use of one of the access mechanisms 20 of thepackage 10 to dispense a pill requires a level of cognitive developmentbeyond that of most children, thereby limiting access by children to thepills. The package 10, however, also provides a senior-friendlyconstruction by which an elderly or infinm person having limitedstrength can nevertheless use the access mechanisms 20 to dispense pillsfrom the package 10.

Referring to the sectional view of FIG. 3, the foil closure layer 14 ispreferably secured to the product casing layer 12 (e.g., by heat sealingthe foil closure layer 14 to a base portion 22 of the product casinglayer 12). As shown in FIG. 3, the foil closure layer 14 extends acrossa lower surface of the product casing layer 12 such that pills 24located within the interiors of blisters 18 are sealed within theblisters 18 by the foil closure layer 14. Preferably, the foil closurelayer 14 has a thickness selected such that the foil closure layer 14,in the absence of the reinforcing layer 16, would rupture in response toa compressive load applied to a pill-containing blister 18 (i.e., by auser pressing down on the blister in a conventional manner). Thepresence of the reinforcing layer 16 beneath the foil closure layer 14,however, prevents a user from dispensing pills from the package 10 inthe conventional manner until the user utilizes one of the accessmechanisms 20 in the manner described below.

Each access mechanism 20 includes a puncturing element 26 carried by theproduct casing layer 12. Preferably, the product casing layer 12 isformed from a moldable plastic material (e.g., an injection moldedplastic) such that the puncturing elements 26 of the access mechanisms20 are integrally defined by the product casing layer 12. The puncturingelement 26 includes a substantially conical outer wall portion 28 and aninner wall portion 30 supported by the outer wall portion 28 such thatthe inner wall portion 30 is located within an interior defined by theouter wall portion 28. As shown, the inner wall portion 30 preferablytapers to a substantially pointed end 32.

Preferably, the inner wall portion 30 and outer wall portion 28 aresubstantially equal in height, as shown, such that the substantiallypointed end 32 of the inner wall portion 30 is located at approximatelythe same level as the base portion 22 of the product casing layer 12.Arranged in this manner, the puncturing element 26 is adapted to deflectwith respect to the surrounding base portion 22 in response to acompressive load applied to the puncturing element 26 (e.g., by a user'sthumb) to drive the substantially pointed end 32 of the inner wallportion 30 into contact with the foil closure layer 14 and thereinforcing layer 16 underlying the puncturing element 26. Thesubstantially pointed end 32 provides a reduced contact area for thepuncturing element 26, thereby increasing the pressure applied to theclosure and reinforcing layers 14, 16 for a given load applied to thepuncturing element 26.

Each access mechanism 20 also includes a tear-away element 34 formedfrom part of the reinforcing layer 16 by a perforation line 36. Asshown, each tear-away element 34 is elongated, and has a first end 38,which is located to underlie the substantially pointed end 32 of thepuncturing element 26 of the access mechanism 20, and an opposite secondend 40, which is located to underlie the blister 18 associated with theaccess mechanism 20. As described above, the puncturing element 26 ofeach access mechanism 20 is adapted to deflect under compressive loadtoward the base portion 22 of the product casing layer 12 such that thesubstantially pointed end 32 of the inner wall portion 30 is driven intocontact with the underlying closure and reinforcing layers 14, 16.

Contact between the substantially pointed end 32 and the layers 14, 16results in pressure being applied to the tear-away element 34 of theaccess mechanism 20 to drivingly separate the first end 38 of thetear-away element 34 from a surrounding portion 42 of the reinforcinglayer 16 to create an access opening in the reinforcing layer 16. Theseparation between the first end 38 of the tear-away element 34 and theportion 42 of reinforcing layer 16 also enables a user to grasp thefirst end 38 and thereby apply a pulling force to the tear-away element34. The pulling force further separates the tear-away element 34 fromthe base portion 42 of the reinforcing layer 16 to extend the accessopening towards the blister 18 located adjacent the second end 40 of thetear-away element 34.

When the tear-away element 34 has been pulled to an extent that theaccess opening in the reinforcing layer 16 extends to a locationunderlying the associated blister 18 in the product casing layer 12, apill contained in the blister 18 may be dispensed. The separationbetween the tear-away element 34 of the access mechanism 20 and thesurrounding base portion 42 of the reinforcing layer 16 results inseparation between the tear-away element 34 and the closure layer 14beneath the blister 18. As such, the portion of the closure layer 14beneath the blister 18 is no longer reinforced by the reinforcing layer16. Application of compressive load to the blister 18 (i.e., in theconventional manner for dispensing pills from blister packages) resultsin contact between a pill contained in the blister 18 and the closurelayer 14 and an associated pressure sufficient to rupture the foilclosure layer 14 and dispense the pill.

Although it is presently preferred that pulling the tear-away element 34separates the tear-away element from the foil closure layer 14, it isnot a requirement. It is conceivable that the foil closure layer 14could be bonded to the tear-away element 34 such that pulling thetear-away element 34 results in a tearing separation between the productcasing layer 12 and a corresponding portion of the foil closure layer 14located atop the tear-away element 34. In this manner, the accessopening created in the reinforcing layer 16 by pulling the tear-awayelement 34 would also extend through the closure layer 14 to communicatewith the interior of the associated blister 18. Such tearing of the foilclosure layer 14 could also be facilitated by including a perforationline in the foil closure layer corresponding to the perforation line 36in the reinforcing layer 16.

As shown, the width of each of the tear-away elements 34 preferablyvaries such that the tear-away element 34 is relatively narrow adjacentthe first end 38. As a result, the amount (i.e., length) of theperforation line 36 over which an applied load is distributed (i.e., theportion of the perforation line 36 that extends around and defines thefirst end 38 of tear-away element 34) is reduced. In this manner, theeffective separating pressure acting on the first end 38 will beincreased compared to that which would be applied were the width notnarrowed at the first end 38. The tendency of the tear-away element 34to separate at the first end 38 can also be increased by increasing thepercentage of perforation (i.e., the discontinuities) in the perforationline 36 adjacent the first end 38 compared to that in other portions ofthe perforation line 36.

The reinforcing layer 16 may be made from polyvinyl chloride (PVC),polyvinylidene chloride (PVDC), or a polychlorotrifluoroethylene (PCTFE)such as Aclar® by Honeywell International. PCTFE is used extensively inpharmaceutical packaging and provides excellent moisture barriercapabilities. The invention, however, is not limited to any particularmaterial for the reinforcing layer and other materials could be used toprovide moisture barrier protection for the product stored within theblisters 18. The reinforcing layer 16 and product casing layer 12 arepreferably secured to each other (e.g., using sonic welding). Thereinforcing layer 16 and product casing layer 12 may be secured togetherat discrete peripheral locations 44, as shown in FIG. 1. Alternatively,the reinforcing layer 16 and product casing layer 12 may be securedtogether along a substantially continuous weld line extending about theperimeter of the product casing layer 12. The bonding between thereinforcing layer 16 and the product casing layer 12 at peripherallocations or along a perimeter line leaves the tear-away elements 34,which are located interiorly from the peripheral locations 44, free toseparate from the product casing layer 12 when the access mechanisms 20are actuated to dispense pills from the package 10 as described above.

To facilitate bonding between the product casing layer 12 and thereinforcing layer 16, the intermediately-located foil closure layer 14could be discontinued at the bonding locations. This is not arequirement of the invention, however, and the bonding (e.g., sonicwelding) between the product casing layer 12 and the reinforcing layer16 could be executed without pre-existing discontinuities being providedin the intermediately located foil layer 14. It is also not arequirement of the invention that the product casing layer 12 be bondedto the reinforcing layer. For example, it is conceived that a hingedpiece of PVC (or other suitable material) could include a portionforming the reinforcing layer 16. The hinged piece would preferably befolded around the product casing layer 12 and foil layer 14 and sealedabout the periphery of the hinged piece such that the product casinglayer 12 and foil layer 14 are captured within the hinged piece.Preferably, the hinged piece defines openings adapted to receive theblisters 18 and puncturing elements 26 of the product casing layer 12.

In the event that sonic welding is used to bond the product casing layer12 and the reinforcing layer 16 at the peripheral bond locations 44 (orperimeter weld line) in the above-described manner, it is conceivablethat the sonic welding apparatus could be adapted to also create theperforation lines 36 in the reinforcing layer 16 that define thetear-away elements 34. Such a feature would desirably facilitatemanufacture by eliminating the need for separate apparatus to performthese functions (i.e., welding and perforating).

As described above, the reinforcing layer 16 of package 10 is depictedwith perforation lines 36 defining the tear-away elements 34. It is nota requirement of the invention, however, that the tear-away elements 34be defined by perforation lines (i.e., spaced discontinuities in thematerial). It is conceivable that other means, such as score lines orotherwise weakened portions of the material, could be used to define theboundaries of the tear-away elements 34 of reinforcing layer 16.

Referring to FIGS. 4 through 6, there is shown a package 46 forpharmaceutical products according to a second exemplary embodiment ofthe invention. The package 46 includes a product casing layer 12, foilclosure layer 14 and reinforcing layer 16 similar in construction to thecorresponding elements of package 10. The package 46, however, alsoincludes a jacket 48 in which the product casing layer 12, foil closurelayer 14 and reinforcing layer 16 are mounted. The jacket 48 of package46 is preferably made from paper (e.g., cardboard) and includes amounting portion 50 having front and back panels 52, 54 between whichthe layers 12, 14, 16 of package 46 are mounted. As shown, the frontpanel 52 of the mounting portion 50 of jacket 48 defines openings inwhich the blisters 18 and puncturing elements 26 of the product casinglayer 12 are received.

Preferably, the back panel 54 of the mounting portion 50 definesopenings 55 at locations that correspond to the locations of theperforation lines 36 in the reinforcing layer 16 of package 46. Such aconstruction facilitates access to the tear-away elements 34 defined byreinforcing layer 16 for grasping and pulling of the tear-away elements34 in the manner described above for package 10. It is conceivable that,instead of defining openings at the locations of the tear-away elements34, the back panel 54 of the mounting portion 50 of jacket 48 coulddefine perforation lines adapted to be torn when the tear-away elementsin reinforcing layer 16 are grasped and pulled.

The jacket 48 could also include a cover panel 56, as shown, and arelatively narrow intermediate panel 58 located between the cover panel56 and the mounting portion 50 of jacket 48. The jacket 48 preferablyincludes fold lines 60, 62 respectively located between the cover panel56 and the intermediate panel 58 and between the intermediate panel 58and the mounting portion 50. Constructed in this manner, the jacket 48is adapted to be opened and closed in book-like fashion. Each of themounting portion 50 and cover panel 56 desirably provides surfaces fordisplay of product indicia and product-related information.

The present invention is not limited to 4 count packages such asdepicted in FIGS. 1 through 6. Referring to FIG. 7, there is shown apackage 64 according the invention having a seven count configuration.Referring to FIG. 8, there is shown a package 66 having a 14 countconfiguration. Each of the packages 64, 66 includes blisters 68 forenclosing a pharmaceutical product such as a pill, capsule or tablet.Each of the packages 64, 66 also includes puncturing elements 70 ofaccess mechanisms for use in dispensing the pharmaceutical products fromthe packages 64, 66 in the above-described manner.

The present invention is also not limited to packaging forpharmaceutical products having any particular shape. Such variation isshown, for example, by comparing the generally elongated shape of theblisters 68 of packages 64, 66 with the generally circular shape of theblisters 18 of packages 10, 46.

The foregoing describes the invention in terms of embodiments foreseenby the inventor for which an enabling description was available,notwithstanding that insubstantial modifications of the invention, notpresently foreseen, may nonetheless represent equivalents thereto.

1. A package for pharmaceutical articles comprising: a casing layerdefining a plurality of blisters each adapted for receipt of one of aplurality of phannaceutical articles; a closure secured to the casinglayer to enclose the articles within the blisters; and a plurality ofpuncturing elements each associated with one of the blisters, thepuncturing element adapted to puncture the closure in response toactuation by a user to create an access opening in the closure, theclosure adapted to prevent a user from compressively deflecting one ofthe blisters to dispense one of the articles from the package until theassociated puncturing element is actuated by the user to create theaccess opening in the closure.
 2. The package according to claim 1,wherein the closure comprises a foil layer and a reinforcing layer, thefoil layer located between the reinforcing layer and the casing layer.3. The package according to claim 1, wherein the puncturing elements aredefined by the casing layer.
 4. The package according to claim 3,wherein each puncturing element includes an outer portion supported bythe casing layer and an inner portion supported by the outer portion,the inner portion tapered to define a pointed end and adapted to deflecttowards the closure in response to compression applied to the puncturingelement by a user.
 5. The package according to claim 4, wherein theouter portion of the puncturing element is substantially conical.
 6. Thepackage according to claim 1, wherein the casing layer comprises amoldable plastic material.
 7. The package according to claim 7, whereinthe puncturing elements are integrally formed with the casing layer fromthe moldable plastic material.
 8. The package according to claim 2,wherein the reinforcing layer includes a plurality of tear-away elementseach extending from a first end located adjacent one of the puncturingelements to an opposite second end located adjacent one of the blisters.9. The package according to claim 8, wherein the tear-away elements aredefined by perforation of the reinforcing layer.
 10. The packageaccording to claim 1 further comprising an outer jacket, the jacketincluding: a mounting portion in which the casing layer, closure andpuncturing elements are mounted; a cover panel; and an intermediatepanel located between the mounting portion and the cover panel such thatthe cover panel is movable with respect to the mounting portion betweenclosed and opened positions.
 11. A package for pharmaceutical articlescomprising: a product casing layer defining a plurality of blisters eachadapted for receipt of one of a plurality of pharmaceutical articles; aclosure secured to the product casing layer to enclose the articleswithin the blisters; and a plurality of access mechanisms eachassociated with one of the blisters of the product casing layer, eachaccess mechanism including a tear-away element defined on a portion ofthe closure and a puncturing element adapted to puncture the closure atthe tear-away element in response to actuation by a user to facilitategrasping of the tear-away element and application of a pulling force bya user, the closure adapted to prevent a user from compressivelydeflecting one of the blisters to dispense one of the articles from thepackage until the access opening is created in the closure by actuationof the puncturing element of the associated access mechanism.
 12. Thepackage according to claim 11, wherein each tear-away element is definedby a perforation line.
 13. The package according to claim 11, whereinthe product casing layer comprises a moldable plastic material andwherein the puncturing elements are integrally formed with the casinglayer from the moldable plastic material.
 14. A package forpharmaceutical articles comprising: a blister pack including a productcasing layer and a foil closure layer, the product casing layer defininga plurality of blisters each adapted for receipt of one of a pluralityof pharmaceutical articles, the foil closure layer secured to theproduct casing layer to enclose the articles within the blisters; areinforcing layer secured to the product closure layer of the blisterpack such that the foil closure layer is located between the productclosure layer and the reinforcing layer, the reinforcing layer adaptedto prevent a user from dispensing an article by compressively deflectingone of the blisters and rupturing the foil layer; and a plurality ofaccess mechanisms each including a puncturing element and a tear-awayelement, the tear-away element defined on a portion of the reinforcinglayer and being elongated to include a first end adjacent the puncturingelement and a second end adjacent an associated one of the blisters, thepuncturing element defined by the product casing layer and including anouter wall portion and an inner wall portion supported by the outer wallportion, the inner wall portion tapered to define a substantiallypointed end and deflectable with respect to the outer wall portion topuncture the reinforcing layer at the first end of the tear-awayelement, the puncturing of the reinforcing layer providing for graspingof the tear-away element by a user and application of a pulling forcesufficient to separate at least a portion of the tear-away element froma surrounding portion of the reinforcing layer, the separation of the atleast a portion of the tear-away element enabling a user to dispense anarticle from the associated blister by application of a compressiveforce to the associated blister to rupture the foil closure layer.